BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU NEUROLINE CONCENTRIC NEEDLE

    MDR report key: 1674817 · Received April 30, 2010

    Report

    Report Number
    9610691-2010-00003
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 27, 2010
    Manufacturer
    AMBU A/S
    Product Code
    IKT
    PMA / PMN Number
    K973529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE HUB WAS RETURNED BY THE CUSTOMER FOR EXAMINATION. THE PART WAS INSPECTED BY MICROSCOPY AND SEVERE STRESS MARKS WERE FOUND ON THE HUB AROUND THE NEEDLE CRIMP AREA. THE MARKS INDICATE THAT THE NEEDLE HAS BEEN BENT IN WIDE ANGLES AT OPPOSITE DIRECTIONS. THE REVIEW OF 20 RETENTION SAMPLES INCLUDING THE LOT INVOLVED DO NOT HAVE ANY STRESS MARKS. AT SIMULATION EXPERIMENTS, IT HAS BEEN DEMONSTRATED THAT BENDING THE NEEDLE AT ANGLES AROUND 60" WILL NOT CAUSE THE NEEDLE TO BREAK EVEN AFTER 50 TIMES OF BENDING IN OPPOSITE DIRECTIONS. WE CONCLUDE THAT THE CAUSE OF THE TIP BROKE OFF IS DUE TO MULTIPLE WIDE ANGLE BENDING. ALTHOUGH OUR NEEDLES MEET (B) (4) BENDING FORCE REQUIREMENTS, THEY CAN BREAK OFF IF THEY ARE BENT AT WIDE ANGLE MULTIPLE TIMES. DURING NORMAL USAGE, THERE IS NO DANGER THAT THE NEEDLE WILL BREAK BECAUSE THEY ARE DESIGNED TO WITHSTAND MANY TIMES OF BENDING WITHIN THE FLEXIBLE LIMIT.

    Description of Event or Problem · 1

    DURING AN EMG, THE TIP OF AN AMBU NEUROLINE CONCENTRIC NEEDLE BROKE OFF INTO A FEMALE PT WHICH REQUIRED A REFERRAL TO A SURGEON FOR REMOVAL. THE TIP WAS SUCCESSFULLY REMOVED ON (B) (6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU NEUROLINE CONCENTRIC NEEDLE SINGLE PATIENT EMG NEEDLE IKT AMBU A/S AMBU NEUROLINE CON 1093134

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other